Clinical Research Associate 2 - (1807879) in Hanoi, VNM at IQVIA™

Job Snapshot

Job Description

Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.PURPOSE
Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. If applicable, Clinical Research Associates may be accountable for development of project subject recruitment plan on a per site basis. Support work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. RESPONSIBILITIES

Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.

If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.

Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.

Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.

Collaborate and liaise with study team members for project execution support as appropriate.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

Strong therapeutic and protocol knowledge as provided in company training

Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

Strong written and verbal communication skills including good command of English language

Strong organizational and problem-solving skills

Effective time management skills

Ability to establish and maintain effective working relationships with coworkers, managers and clients

Job Requirements

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelor's degree in a health care or other scientific discipline or educational equivalent and 1 year of on-site monitoring experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS

Extensive use of telephone and face-to-face communication requiring accurate perception of speech

Extensive use of keyboard requiring repetitive motion of fingers

Regular sitting for extended periods of time

Requires frequent travel to sites

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.